AQUA Laminoplasty Systems— 510(k) K252930

Name: FDA 510(k) clearance K252930
Creator: U.S. Food and Drug Administration
Published: 2026-05-27

Substantially Equivalent

ZheJiang Decans Medical Devices Co., Ltd.

FDA 510(k) clearance K252930 for AQUA Laminoplasty Systems, Substantially Equivalent on 2026-05-27. Applicant: ZheJiang Decans Medical Devices Co., Ltd.. Device class: 2.

Clearance details

Applicant: ZheJiang Decans Medical Devices Co., Ltd.
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2025-09-15
Decision date: 2026-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.